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A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01249196
Recruitment Status : Completed
First Posted : November 29, 2010
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: SK-PC-B70M Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2010
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: SK-PC-B70M
for dosage
Experimental: SK-PC-B70M 200mg bid Drug: SK-PC-B70M
for dosage
Experimental: SK-PC-B70M 300mg bid Drug: SK-PC-B70M
for dosage
Donepezil Drug: SK-PC-B70M
for dosage


Outcome Measures
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Primary Outcome Measures :
  1. ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input) [ Time Frame: 45 minutes ]
  2. MMSE (Mini Mental State Examination) [ Time Frame: 10 minutes ]
  3. CDR-SB (Clinical Dementia Rating Sum of Box) [ Time Frame: 20 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria)
  • MRI within the last 12 months consistent with a diagnosis of AD
  • MMSE score of 10 to 26 and CDR of 1 or 2
  • AChEI or memantine was not taken at least 3 months prior to screening

Exclusion Criteria:

  • Other central nervous disease
  • Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS
  • T.I.A or Major infarction within the last 12 months
  • Any serious disorder that could limit the ability of the patient to participate in the study
  • COPD or asthma
  • Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249196


Locations
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Korea, Republic of
SKChemicals invetigational site
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co., Ltd.
More Information
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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01249196    
Other Study ID Numbers: SMART_AD_III_2009
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2010
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders